A UK-Based Cost-Utility Analysis of Indacaterol, A Once-Daily Maintenance Bronchodilator for Patients with COPD, Using Real World Evidence on Resource Use

Abstract

IntroductionChronic Obstructive Pulmonary Disease (COPD) is a chronic, progressive disease that is not curable. However, there are effective treatments available. In the UK, long-acting bronchodilators are first-line treatments for COPD patients requiring maintenance therapy, and there are several options available. The aim of this study is to establish, from the UK National Health Service (NHS) perspective, the cost-effectiveness profile of indacaterol, the first once-daily long-acting beta2-agonist (LABA), compared with tiotropium and salmeterol, in patients with moderate to severe COPD. In assessing the cost-effectiveness of COPD therapies, this study has the advantage of using real world evidence on the resource use associated with COPD management across the spectrum of the disease.MethodsA Markov model was developed with four health states following the GOLD classification for severity of airflow limitation. The model time horizon was 3 years, and the cycle length was 3 months. From each state, patients could experience a severe or non-severe exacerbation, move to a different COPD state, remain in the current state or die. Transition probabilities were based on data from the indacaterol clinical trials. The majority of the resource use data was taken from the Optimum Patient Care Research Database (OPCRD), which contains data from over 20,000 COPD patients in England and Scotland. Cost data were taken from UK-based sources and published literature and presented for the cost year 2011. Health-related quality of life was the main outcome of interest and utility data for the COPD states were based on data from the indacaterol clinical trials and disutility due to exacerbations were taken from the literature. Both one way and probabilistic sensitivity analyses were performed to test the robustness of the results.ResultsIndacaterol dominated in the comparison with salmeterol producing an incremental QALY gain of 0.008 and cost savings of £110 per patient over a 3-year time horizon. In the comparison with tiotropium over the same time horizon, indacaterol remained the dominant strategy, producing an incremental QALY gain of 0.008 and cost savings of £248 per patient. The one-way sensitivity analysis indicates that the proportion of patients in each of the COPD stages and the mortality rate associated with Very Severe COPD are the variables with the largest impact on the results. The probabilistic sensitivity analyses showed that over 72 % and 89 % of the iterations when compared with salmeterol and tiotropium, respectively, produced dominant results for indacaterol.ConclusionThe analyses demonstrate that indacaterol dominates both tiotropium and salmeterol in the base case and is likely to remain cost-effective under a range of assumptions.

Progress and Prospects for Long-Acting Β 2 -Agonists in the Treatment of Chronic Obstructive Pulmonary Disease (Copd)

“…Although, as already mentioned,indacaterol is cost-effective compared to tiotropium and salmeterol [33] and notwithstanding what we have previously illustrated on the potential positioning of ultra-LABAs in the treatment of COPD, no guideline indicates ultraLABAs as first choice drugs compared to LAMAs. In effect, there is not published evidence that ultraLABAs are definitely more effective than LAMAs as monotherapy.…”

“…In a pooled analysis of data from three randomized, double blind, placebo-controlled studies, both indacaterol doses, 150 and 300 μg, were associated with significant reductions in exacerbations versus placebo [29]. However, the Indacaterol: providing opportunity to re-engage patients with life (INVIGORATE) study showed that tiotropium offered greater protection from exacerbations than indacaterol [30], but the absolute number of events was small and the difference between treatments was of uncertain clinical importance.A post hoc analysis has shown that blood eosinophil count ≥2%, which is a promising biomarker of response to ICSs in patients with COPD [31], does not appear to predict bronchodilator response to β 2 -agonists in either ICS users or non-users [32].It is remarkable to point out that a UK-based cost-utility analysis of indacateroldemonstrated that indacaterol can produce better outcomes at a lower cost to the healthcare system compared with both tiotropium and salmeterol and is likely to remain cost-effective under a range of assumptions [33]. In particular, the proportion of patients in each of the COPD stages and the mortality rate associated with very severe COPD are the variables with the largest impact on the results.…”

“…It is remarkable to point out that a UK-based cost-utility analysis of indacateroldemonstrated that indacaterol can produce better outcomes at a lower cost to the healthcare system compared with both tiotropium and salmeterol and is likely to remain cost-effective under a range of assumptions [33]. In particular, the proportion of patients in each of the COPD stages and the mortality rate associated with very severe COPD are the variables with the largest impact on the results.…”

Progress and Prospects for Long-Acting Β 2 -Agonists in the Treatment of Chronic Obstructive Pulmonary Disease

“…Необходимо отметить, что проведенный в Ве-ликобритании анализ рентабельности применения индакатерола показал, что индакатерол обеспечи-вал лучшие результаты при меньшей стоимости по сравнению с тиотропием и сальметеролом и, скорее всего, остается экономически эффективным по ряду положений [33]. В частности, доля больных с каждой из стадий ХОБЛ и уровень смертности, связанной с крайне тяжелой ХОБЛ, являются наиболее значимы-ми параметрами, влияющими на результат лечения.…”

Real-world evidence in economic evaluations: Really realistic?

“…The British study 8 compared indacaterol (the sponsored drug) with tiotropium and salmeterol in patients with chronic obstructive pulmonary disease. Efficacy and utility were derived from multi-centre international randomised controlled trials on indacaterol, chronic obstructive pulmonary disease-related mortality rates from a Spanish economic evaluation.…”